Does Patient Blinding Influence Clinical Outcomes After Annular Closure Device Implantation? A Propensity Score-Matched Analysis.

ABSTRACT:

Background

Awareness of treatment group assignment in a clinical trial may influence patient behavior and bias outcome reporting. The objective of this study was to compare 2-year clinical outcomes in blinded vs unblinded patients who were treated with lumbar discectomy and a bone-anchored annular closure device (ACD) for prevention of lumbar disc reherniation.

Methods

This was a secondary analysis of a randomized trial comparing lumbar discectomy with (n=272) vs without (n=278) implantation of a bone-anchored ACD. Among patients who received ACD implantation, 35 (13%) were blinded and 237 (87%) were unblinded to treatment allocation. In patients treated with ACD, propensity score-matching (1:1) was performed to account for imbalances in patient characteristics between blind

SUBMITTER: Bouma GJ 

PROVIDER: S-EPMC6850684 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature